FDA’s Two Big Moves on NGS-Based Tumor Panels May Offer Clues for Alternative Pathways for LDT Approval

In late November the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center’s Integrated Mutation Profiling of Actionable Cancer Targets tumor profiling test assay (MSK-IMPACT) and approved FoundationOne CDx (F1CDx), Foundation Medicine’s comprehensive, next-generation sequencing- (NGS-) based companion diagnostic (CDx) test for solid tumors. While personalized medicine advocates can certainly hail these regulatory wins as progress towards greater adoption and reimbursement of comprehensive molecular panels in routine cancer care, the FDA’s actions may also offer some more subtle clues for potential innovative regulatory pathways the agency may be exploring for laboratory-developed tests (LDTs). Unlike previous FDA CDx approvals that match one test to one drug, Foundation Medicine’s F1CDx enables matching of patients with five different tumor types to 15 different approved, targeted treatments. In the case of MSK-IMPACT, the FDA not only authorized the panel, but it also established a lighter regulatory pathway for the review of subsequent NGS-based tumor profiling assays, including the appointment of a third-party reviewer for such tests. In approving F1CDx through the Parallel Review Program in concert with the Centers for Medicare & Medicaid Services, the FDA is furthering regulatory mechanisms that enable faster reimbursement and adoption of emerging, innovative technologies. The […]